—#124791

Product

SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.

FDA product code: KPQ — System, Simulation, Radiation Therapy
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K953233
Affected lot / code info: SIMVIEW NT Part number: 5496992 SIMVIEW NT with IDI Part number: 5497016 US Serial numbers: 6019 6029 6032 6035 6068 6080 6001 International serial numbers: 6060 6027 6067 1236 3654 4190 6006 6007 6014 6015 6020 6022 6023 6024 6030 6042 6048 6049 6053 6054 6062 6065 6069 6070 6084 6085 6088 6092 6095 6098 6099 6103 6104 6041DEL 6099-1 1256 6017 6028 6034 6036 6041 6044 6047 6050 6052 6055 6056 6058 6066 6072 6073 6079 6082 6083 6089 6090 6093 6105.

Why it was recalled

In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens sent an Urgent Field Safety Notice to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. What preventive measures can the user take? To stop the movement in this case, push the emergency button / stop button at control console or push the in-room emergency button. The emergency button/ stop button functionality is described in the User Manual. There is no preventive measure to avoid this situation. This letter is intended to bring this potential safety issue to your awareness and to ensure that your personnel are trained about the use of the emergency button / stop button inside the simulation room and on the control console. Always monitor any movement of the simulator components. The Update Instruction containing the Urgent Field Safety Notice will be delivered by the Siemens Customer Service Group, as per their procedure Siemens is working on a solution to mitigate the described situation. You will be informed as soon as the update distributing this solution is available. Please include this Field Safety Notice in your SimView NT Simulator System Owner Manual chapter Safety Advisory Letters where it should remain. In the interests of safety, we ask that you perform the described preventive measures and inform all affected personnel immediately. The relevant National Competent Authority has been informed of this Customer Safety Advisory Notice. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. For further questions please call (925) 602-8157.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 757 Arnold Dr, Ste A, Martinez, California 94553-3615

Distribution

Distribution pattern: Class II Recall - Worldwide Distribution - US Distribution including the states of California, Louisiana, Massachusetts, Pennsylvania, New York, Kentucky and Michigan., and the countries of Bulgaria, Germany, Belarus, Russian Fed., P.R. China, India, Republic Korea, Germany, Costa Rica, Argentina, Portugal, Greece, Bulgaria, Vietnam, Hungary, Italy, Palestinian Ter, Hungary, Jordan, Egypt Poland, Greece, Curacao, St Eus, Malaysia, Egypt, Malaysia, South Africa Turkey, Thailand, Qatar and Iraq.

Timeline

Recall initiated: 2013-12-11
Posted by FDA: 2014-01-17
Terminated: 2014-03-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124791. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.